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Author: John Robinson
Displaying 201 to 210 of 270 articles < Back | Next >
Pages: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27
 Articles by John Robinson 
201. 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Config
November 24, 2013

Overview: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional r...

202. Software Validation Planning for Executives and Managers - Webinar by GlobalCompliancePanel
November 24, 2013

Overview: This webinar is intended for executives and managers, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11.

This webinar details how to ass...

203. Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements fro
November 24, 2013

Overview: The webinar will define the terms associated with technology transfer and describe the requirements for a Technology Transfer Policy and the corresponding documentation. The policy will include the selection of a Tech. Transfer team, the development of a specific plan for each case and the...

204. Understanding Analytical Test Results: Comparing Two Sets of Data - Webinar by GlobalCompliancePane
November 24, 2013

Overview: The class will cover the understanding the properties of single test results and how they may be compared. There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover...

205. Electronic Informed Consent for Clinical Trials: Why, What and How - Webinar by GlobalCompliancePan
November 24, 2013

Overview: This webinar will present an exploration of trends that are leading to adoption of e-consent; options are available for e-consent, what is involved in implementing e-consent. A live demonstration of an e-consent will set the stage for implementation questions.

Why Should You Atten...

206. Device Corrections and Removals - Webinar by GlobalCompliancePanel
November 24, 2013

Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections an...

207. Medical Device Complaint Handling: MDR, Reports of Removals and Corrections - Webinar by GlobalCom
November 24, 2013

Overview: This presentation will step through the FDA regulations relating to post-market product problems, and give examples of how FDA currently interprets these regulations. Following this presentation, you should be able to decide whether your customer complaint requires not only investigation, ...

208. FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes - Webinar by
November 24, 2013

Overview: Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible.

Be careful! You need to know what information can (and more importantly) CANNOT be present on the labeling. This presentation ...

209. Determining the Necessary Laboratory Water Specifications and Simplifying Water System Validation -
November 24, 2013

Overview: This webinar will assist the attendees in logically investigating and defining the specific quality attributes their lab water systems need and not just default to manufacturing's required water quality. The need or lack thereof to validate your water system will also be discussed along wi...

210. Controlled Document System for a Life Sciences manufacturing plant - principles of Lean Documents a
November 24, 2013

Overview: Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

This webinar app...

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TIM FAY

I am not a writer nor am I trying to become a writer. I am an average person with average intelligen...more
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Cecilia is a professional Editor-writer (30+ years) and works on a worldwide scale. She has a profes...more
PAUL RICE

hello everyone l been on the net since 2000 and enjoy my work l work as an affiliate and also have w...more

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